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现行 ISO/TR 19693:2018
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Surface chemical analysis — Characterization of functional glass substrates for biosensing applications 表面化学分析 - 用于生物传感应用的功能性玻璃基底的表征
发布日期: 2018-02-09
ISO/TR 19693:2018举例说明了ISO TC 201范围内的表面化学分析方法如何有助于表征用于生产生物传感装置的基质的性质。成功的表征将使人们有机会更好地了解表面化学性质和生产过程中影响最终设备整体性能的每个步骤的反应,例如微阵列。制备的步骤是通过固定连接分子激活底物,并用特定生物传感所需的生物分子对活化底物进行功能化- 叫做探测器。 在此,重点是基于硅烷的玻片功能化,这是后续固定探针分子的关键生产步骤。这些探针用于感知生物识别事件。之所以选择硅烷化工艺,是因为它是当今生物传感器生产中最流行的工艺之一。 ISO/TR 19693:2018概述了识别基板、设备生产步骤(清洁、活化和化学改性)和货架相关问题可能来源的方法、策略和指南- 寿命(储存条件和老化)。它特别适用于表征玻璃基生物传感器的表面化学分析员,以及生物传感设备生产社区的开发人员或质量经理。基于定量和定性的表面化学分析,可以制定和实施在设备制造过程中识别性能不佳原因的策略。本文件显示了今天的光照距离,以及未来ISO/TC 201更具体活动的可能起点,这些活动以标准化的测量程序结束。 本文件未讨论有关处理的具体协议。要了解有关协议的更多信息,请参考专门文献,例如参考文献[1]至[9]。
ISO/TR 19693:2018 gives examples of how methods of surface chemical analysis in the scope of ISO TC 201 are useful to characterize the nature of substrates used to produce biosensing devices. Successful characterization will give the opportunity for a better understanding of aspects of surface chemistries and reactions at each step of production influencing the overall performance of the final device, for example a microarray. The steps of preparation are the activation of the substrate by immobilization of linker molecules and the functionalization of the activated substrate with biomolecules required for specific biosensing, the so-called probes. Herein, a focus is set on silane-based functionalization of glass slides, a critical production step for subsequent immobilization of probe molecules. Those probes are used for sensing of biological recognition events. The silanization process has been selected because it is one of the most popular in biosensor production today. ISO/TR 19693:2018 gives an overview of methods, strategies and guidance to identify possible sources of problems related to substrates, device production steps (cleaning, activation and chemical modification) and shelf-life (storage conditions and ageing). It is particularly relevant for surface chemical analysts characterizing glass-based biosensors, as well as developers or quality managers in the biosensing device production community. Based on quantitative and qualitative surface chemical analysis, strategies for identifying the cause of poor performance during device manufacturing can be developed and implemented. This document shows how far the light may shine today and possible starting points for more specific activities of ISO/TC 201 in the future, which end in standardized procedures for measurements. No specific protocols on processing are discussed in this document. To learn more about protocols the reader is referred to specialized literature, see for example References [1] to [9].
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归口单位: ISO/TC 201
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